10-25-2018 Agenda

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AGENDA Nonclinical SDRG Team Meeting Thursday, Oct 25, 2018

  • New FDA Business Rule with nSDRG impact: The interval of time to detection of a tumor for each organ/tissue should be consistent between SEND (TFDETECT) and Tumor.xpt (DETECTTM). Explain any inconsistencies in the nSDRG.
  • New TCG - Analysis for impacts